Kornimate/medical-research-clean huggingface dataset:
phase i/ii trial of stereotactic body radiotherapy with concurrent fixed dose tyrosine kinase inhibitors in metastatic renal cell carcinoma: dose limiting toxicity and abscopal effect.

Conditions: Carcinoma, Renal Cell

Summary: tyrosine kinase inhibitors (tkis) are often used in the standard treatment for patients with metastasized renal cell carcinoma. in addition to their ability to specifically inhibit tumor growth, tkis also interfere with the vascularisation of the tumor. unfortunately, most patients do not obtain long-lasting clinical benefit from this treatment. the goal of the current study is to enhance the effect of tkis by combining them with stereotactic radiotherapy treatment of one of the metastases. this type of radiotherapy allows us to precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. recently it has been demonstrated that this type of radiotherapy stimulates the immune system to attack the tumor. by combining stereotactic radiotherapy with tkis we expect to observe a reduction of metastases in a bigger population of patients. in the first part of our study we focus on the safety of the combination therapy. in the second part we will evaluate the combined treatment response.


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of rcc with clear-cell component histology * at least 3 extracranial measurable metastatic lesions per recist * karnofsky performance score \>60 * patients should have undergone cytoreductive treatment of their rcc at least 6 weeks prior to inclusion * patients should have adequate organ function for tki treatment. exclusion criteria: * prior systemic treatment for rcc * uncontrolled central nervous metastases * prior radiotherapy interfering with sbrt * any disorder precluding understanding of trial information.
family routines enhancing adolescent diabetes by optimizing management

Conditions: Type 1 Diabetes

Summary: a three month randomized study to examine the potential benefits of sleep extension in tandem with clinical trial on diabetes management in youth with type 1 diabetes.

type 1 diabetes (t1dm) is one of the most common chronic medical conditions that occur in children. more than two-thirds of these young patients struggle to maintain optimal glycemic control. on a seemingly unrelated front, insufficient sleep has become a public health crisis as less than 30% of youth achieve the recommended number of hours on school nights. prior research has supported that sleep disturbances contribute to elevated glucose levels and have a significant impact on memory, attention, and planning. these skills are essential to effective diabetes management. despite the link between sleep and diabetes, no research has examined the benefits of an intervention to help these youth achieve a healthy sleep duration. to that end, our primary objective is to determine the effect of sleep extension on glycemic control and psychosocial functioning. our secondary objective is to determine mediators and moderators of effect. the central hypothesis is that an increase in sleep duration will lower glucose levels and improve behavioral ratings (internalizing, externalizing, and classroom behaviors). our primary study aims are to (1) test if lengthening sleep improves glycemic control and psychosocial function in youth with t1dm; (2) assess putative mechanisms for the effects of sleep extension on glucose and psychosocial function; and (3) examine the possible moderating effect of pre-existing sleep parameters and sociodemographic variables that modify the impact of sleep extension. a secondary aim is exploratory to examine additional pre-selected mediators and moderators. in the proposed randomized study, up to 175 youth with t1dm will be assigned to a sleep extension or a supportive routines condition. the sleep extension lengthens youth's time in bed to allow for a healthy sleep duration on a consistent basis, whereas the supportive routines condition reinforces daytime and nighttime activities. we will test the impact of sleep extension on key indices of glycemic control (average glucose levels and % time hyperglycemia using continuous glucose monitors and hba1c) as well as putative mechanisms of effect (e.g., heart rate variability and salivary cortisol levels) and participant characteristics that might mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and ses). once our aims are achieved and a causal link is established, the proposed sleep extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with t1dm.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * neurological, developmental, or psychiatric condition that in the opinion of the pi would significantly interfere with sleep or participation * not hospitalized within the previous month prior to enrollment

Keywords: youth diabetes management sleep
multidimensional accurate diagnosis and treatment technology and clinical transformation of type 2 diabetes nephropathy

Conditions: Diabetic Nephropathy Type 2; Diabetic Kidney Disease; Type 2 Diabetes

Summary: diabetes nephropathy (dn) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. there is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional chinese and western medicine.


Eligibility criteria:
inclusion criteria: age ≥ 18 years old, regardless of gender; type 2 diabetes; having a complete medical history and clinical data; if the patients with type 2 diabetes combined with ckd underwent renal biopsy, the pathological diagnosis should be clear; patients voluntarily signs an informed consent form. exclusion criteria: incomplete medical history or clinical data; patients with hereditary kidney disease; combined urinary tract infection; merge autoimmune system diseases; patients with malignant tumor were expected to survive less than 6 months; pregnancy and lactation.

Keywords: diabetic nephropathy type 2 diabetic kidney disease type 2 diabetes diagnosis treatment
supporting patient decisions about ue surgery in cervical sci

Conditions: Cervical Spinal Cord Injury

Summary: the goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants: 1. nerve or tendon transfer recipients: people who have elected to undergo nerve (n=10) or tendon (n=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (n=20) 2. non-surgical control group: people with cervical sci (n=20) and their caregiver (n=20)

at present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options. understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. ultimately, this project will create a decision support intervention (dsi) that can be used to help clinicians and people living with cervical level sci and their caregivers. it will be most useful to those with acute or sub-acute injury (\< 1year after sci) for both military personnel and the general public. clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function. in such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.

Eligibility criteria:
cervical spinal cord injury participants inclusion criteria: * adult subjects (≥18 years and \< 80 years) with cervical level sci asia a, b or c (minimum 6 months and maximum 20 years post-injury). exclusion criteria: * patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other) * patient has asia d status (these patients may have progressive return of functionally useful motor function below the level of the sci and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population). caregiver participants inclusion criteria: * at least 18 years of age * able to answer questions about the primary participant's experiences with cervical spinal cord injury exclusion criteria: * the caregiver/spouse declines to participate in the study. note: caregiver participation is preferred, but not required, for sci participant enrollment.

Keywords: nerve transfer surgery tendon transfer surgery decision support intervention
efficacy study for the symptomatic treatment of chronic idiopathic urticaria

Conditions: Urticaria

Summary: the objective of the study is to evaluate the efficacy and tolerability of bilastine 20 mg q.d., compared to levocetirizine 5 mg q.d. and placebo for the treatment of chronic idiopathic urticaria.

a total of 540 patients with ciu will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . patients will be selected from both public and private clinical practices. the study population includes males and females between 18 and 70 years of age, suffering from ciu for at least 6 weeks prior to entry in the study with no identifiable cause.

Eligibility criteria:
inclusion criteria: * 18 to 70 years old. * documented history of ciu for at least 6 weeks prior to entry in the study. exclusion criteria: * dermatological pathology other than chronic idiopathic urticaria. * history of autoimmune disorders, hodgkin's disease, lymphoma, leukemia and generalized cancer. * pregnant or breast-feeding women. * patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession. * patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse. * patients who are currently participating in or have participated in another clinical trial within the last 3 months

Keywords: urticaria hives wheals flare chronic idiopathic erythema skin diseases, vascular hypersensitivity, immediate allergic cutaneous
a clinical trial of tqb3015 tablets in patients with advanced malignant cancer

Conditions: Advanced Malignant Neoplasm

Summary: this study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. this is a single-center, open, non randomized, single arm study to the safety and tolerability of tqb3015 tables in patients with advanced malignant cancer.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * age: 18 to 75 years old; an eastern cooperative oncology group (ecog) performance status of 0 or 1; * advanced malignant tumors confirmed by tissue or cellular pathology and the routine standard treatment was ineffective or lack of effective treatment plans, or patients cannot tolerate the standard treatment; * has at least one assessable lesion according to response evaluation criteria in solid tumors (recist) version 1.1 criteria; * the main organs function well; * female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period and until at least 6 months after the last dose of study drug. exclusion criteria: * concomitant disease and medical history: 1. there were other malignant tumors occured within 3 years before the first dose of study drug. 2. has multiple factors affecting oral medication; 3. unalleviated toxicity ≥ grade 1 according to ctcae v5.0 due to any previous therapy, excluding hair loss; 4. major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period; 5. arteriovenous thrombotic events occurred within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 6. have a history of psychotropic drug abuse and can not quit or have mental disorders; 7. subjects with any severe and/or uncontrolled disease including active hepatitis, immunodeficiency; * tumor-related symptoms and treatment: 1. has known symptomatic central nervous system metastases and/or cancerous meningitis; 2. have received surgery, chemotherapy, radiation therapy (2 weeks for brain radiation therapy) or other anti-cancer therapies within 4 weeks prior to the first dose. 3. thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time. 4. has participated in other clinical trials within 4 weeks before first dose. * according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
dexmedetomidine versus propofol for prolonged sedation in poly traumatized mechanically ventilated patients

Conditions: Trauma

Summary: dexmedetomidine, a central and peripheral α2-receptor agonist distinct from gaba receptor for benzodiazepines and propofol, has been approved by the us food and drug administration only for use up to 24 h in mechanically ventilated patients. the investigators aim to compare dexmedetomidine with propofol for sedation \>24h in poly traumatized mechanically ventilated patients.

the importance of optimizing the levels of sedation in critical care has been increasingly recognized. many intensive care experts are focusing on maintaining a targeted ''ideal'' sedation level according to the individual patient's condition to avoid adverse events such as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium, psychological problems, and increased treatment costs resulting from over sedation. dexmedetomidine is a selective alpha-2-adrenoceptor agonist. it exerts both sedative and analgesic effects via mechanisms different from other sedatives such as midazolam and propofol, and provides sedation characterized by prompt response to stimuli with no respiratory depression. the investigators aim to compare dexmedetomidine with propofol for sedation \>24h in poly traumatized mechanically ventilated patients. the investigators will perform a prospective, single center trial to investigate the safety and efficacy of dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated icu patients, in comparison with propofol.

Eligibility criteria:
inclusion criteria: * endotracheal intubation * mechanical ventilation * poly traumatized * icu patients and estimated duration of sedation\>24 h. exclusion criteria: * patients with serious trauma in the central nervous system, * with bleeding probably requiring surgical hemostasis, * drug overdose within the last 30 days before study entry, * pregnancy/lactation, * contraindication to alpha-2-adrenoceptor agonists or antagonists, * cardiovascular disease, * conduction disturbances or difficulty in data collection or completing the study protocol
weight loss for couples

Conditions: Overweight; Obesity

Summary: obesity risk is shared within married couples yet most existing weight loss programs focus on individuals and not the marital dyad. this project will test the effects of a couples weight loss program that teaches spouses how to provide each other with autonomy support and create an interpersonal environment that promotes sustained behavior change.


Eligibility criteria:
inclusion criteria: 18-70 years old interested in receiving free weight loss treatment with their spouse have a body mass index (bmi) between 25 and 45 kg/m2. individuals who respond to the advertisement will be screened for eligibility by phone. eligibility will be limited to married/cohabitating couples (n=64) in which each spouse is 18-70 years old with a bmi between 25-45 kg/m2. exclusion criteria: currently in a weight loss program, dieting, or taking medications that might affect weight participated in a weight loss program in the past year have lost \> 10% of body weight during past 6 months are currently participating in any other research study that may interfere with this study are pregnant, lactating, \< 6 months postpartum, or plan to become pregnant during the study have undergone cancer treatment within the past year, not including skin cancer treatment have substance abuse, dependence, average more than 14 drinks per week, or are currently being treated for alcohol or substance abuse have a heart condition, chest pain during periods of activity or rest, or loss of consciousness report uncontrolled hypertension, history of coronary heart disease, stroke, peripheral arterial disease or have a blood pressure ≥160/100 mmhg as measured by study staff at baseline report chronic gastrointestinal disease endorse having hepatitis b or c, cirrhosis, or hiv; or report a significant psychiatric illness that may interfere with completion of the study deemed by study staff to be unlikely to adhere to study protocol (e.g. moving in the next 12 months).

Keywords: couples weight loss treatment home environment
the peripheral blood multi-omics study on sleep loss

Conditions: Sleep Deprivation; Aging; Alzheimer Disease; Healthy Lifestyle; Cognitive Decline; Shift-work Disorder

Summary: sleep plays a role in cognitive processes such as memory processing, attention processing, and overall cognitive function. in recent years, the bidirectional relationship between sleep loss and aging, as well as related neurodegenerative diseases, has garnered widespread attention. sleep disorders are a typical clinical manifestation of neurodegenerative diseases such as alzheimer's disease (ad) and parkinson's disease and are closely related to the progression of these diseases. however, current research has yet to fully elucidate the physiological responses to sleep loss across different ages and cognitive levels, as well as the association and molecular basis between sleep loss, aging, and neurodegenerative diseases. this study aims to comprehensively characterize the transcriptional and metabolic changes in peripheral blood under sleep loss in populations of different ages and cognitive levels using multi-omics approaches and to preliminarily explore the role of sleep deprivation in aging and ad.

participants meeting inclusion and exclusion criteria will include healthy subjects, mci patients, and ad patients. general information such as age, gender, education level, medical history, family history, medication history, and surgical history will be collected. cognitive assessments and sleep condition screenings will be conducted, with blood samples collected before and after sleep deprivation, and anxiety and depression scales administered. blood samples will be processed using standardized methods for multi-omics analysis. joint analyses with cognitive levels and sleep conditions will be performed to identify molecular biomarkers associated with age, cognitive levels, and key biological processes related to sleep deprivation, revealing its association with aging and ad.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form； 2. meet the inclusion criteria for each arms. exclusion criteria: 1. failure to provide informed consent; 2. inability to follow study procedures due to issues such as language barriers or cognitive impairment; 3. regular use of medications that may alter the relationship between sleep and outcome variables (e.g., opioid medications, benzodiazepines, and z drugs \[non-benzodiazepine hypnotics\]); 4. history of alcohol abuse, substance abuse, consciousness disorders, cerebrovascular disease, head injury, epilepsy, encephalitis, or other neurological disorders; 5. diagnosis of schizophrenia, severe depression, anxiety disorders, or other severe psychiatric conditions; 6. presence of severe arrhythmias, myocardial infarction within the last 6 months, severe pulmonary dysfunction, renal or hepatic insufficiency, severe anemia, severe gastrointestinal diseases, tumors, or other severe medical conditions.

Keywords: sleep loss multi-omics metabolome aging alzheimer's disease